NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device
Medical device recall Z-2160-2024. Published in FDA’s Enforcement Report on Jun 26, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 26, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1316936 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
1316936 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog Number: RFP-400, Primary Device Identifier: M535RFP4000; Catalog Number: RFP-401, Primary Device Identifier: M535RFP4010; Catalog Number: RFP-402, Primary Device Identifier: M535RFP4020; Catalog Number: RFP-403, Primary Device…
Every code shown here, 1,998 characters
Catalog Number: RFP-400, Primary Device Identifier: M535RFP4000; Catalog Number: RFP-401, Primary Device Identifier: M535RFP4010; Catalog Number: RFP-402, Primary Device Identifier: M535RFP4020; Catalog Number: RFP-403, Primary Device Identifier: M535RFP4030; Catalog Number: RFP-404, Primary Device Identifier: M535RFP4040; Catalog Number: RFP-405, Primary Device Identifier: M535RFP4050; Catalog Number: RFP-406, Primary Device Identifier: M535RFP4060; Catalog Number: RFP-453, Primary Device Identifier: M535RFP4530; Catalog Number: RFP-454, Primary Device Identifier: M535RFP4540; Catalog Number: RFP-456, Primary Device Identifier: M535RFP4560; RFP-400 Lot Numbers: Q2211552 Q2211554 Q2211553 Q2211312 Q2211551 Q2211555 Q2211313 Q2211314 Q2211556 Q2211315 Q2301381 Q2302705 Q2302703 Q2302706 Q2302704 Q2303710 Q2303737 Q2303709 Q2303790 Q2303708 Q2303707 Q2304269 Q2304267 Q2304268 Q2305365 Q2305429 Q2305366 Q2305416 Q2305594 Q2305428 Q2306919 Q2306918 Q2306834 Q2306921 Q2306833 Q2306917 Q2306996 Q2306915 Q2306920 Q2306916 Q2306922 Q2306679 Q2306832 Q2308427 Q2308425 Q2308426 Q2309805 Q2309803 Q2309798 Q2309801 Q2309804 Q2309802 Q2309800 Q2309799 Q2310032 Q2310033 Q2310031 Q2310029 Q2310030 Q2311574 Q2311570 Q2311569 Q2311572 Q2311567 Q2311573 Q2311568 Q2311571 Q2401156 Q2401151 Q2401152 Q2401157 Q2401154 Q2401155 Q2401153 Q2401150 Q2402456 Q2402428 Q2402454 Q2402628 Q2402458 Q2402630 Q2402455 Q2402627 Q2402457 Q2402429; RFP-401 Lot Numbers: Q2211399 Q2211325 Q2211402 Q2211473 Q2211470 Q2211324 Q2211316 Q2211318 Q2211395 Q2211403 Q2211484 Q2211474 Q2211317 Q2211401 Q2211323 Q2211394 Q2211398 Q2211319 Q2211472 Q2211396 Q2211406 Q2211397 Q2211479 Q2211481 Q2211404 Q2211322 Q2211546 Q2211321 Q2211405 Q2211480 Q2211471 Q2211477 Q2211476 Q2211485 Q2211320 Q2211478 Q2211475 Q2211400 Q2212628 Q2212629 Q2212630 Q2301023 Q2301373 Q2301104 Q2301105 Q2301025 Q2301244 Q2301245 Q2301024 Q2301248 Q2301376 Q2301374 Q2301026 Q2301246 Q2301175 Q2301103 Q2301182 Q2301247 Q2301179 Q2301375…
FDA’s list runs to 7,362 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 14, 2024.
- FDA classified it on Jun 20, 2024.
- FDA’s Enforcement Report published it on Jun 26, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- NxStage Medical Inc, of Lawrence, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,362 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.